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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC

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BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC Back to Search Results
Model Number 39200
Device Problems Fracture (1260); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2023
Event Type  Injury  
Manufacturer Narrative
B3 - date of event: used the first date of the month of the aware date as no event date was provided.
 
Event Description
It was reported that stent migration and fracture occurred.A 12x40x75 epic vascular stent migrated and upon retrieving the migrated stent, it fragmented.No further information was reported.
 
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Brand Name
EPIC VASCULAR
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17967985
MDR Text Key326079661
Report Number2124215-2023-52639
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729805151
UDI-Public08714729805151
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number39200
Device Catalogue Number39200
Device Lot Number0030871458
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/21/2023
Initial Date FDA Received10/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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